YY/T 0586-2016: Medical polymer products - Test methods of radiopacity

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Scope

The test methods in this Standard cover the determination of the radiopacity of
materials and products utilizing X-ray based techniques, including fluoroscopy,
angiography, CT (computed tomography) and DEXA (dual energy X-ray
absorptiometry), also known as DXA. The results of these measurements are an
indication of the likelihood of locating the product within the human body.
Radiopacity is determined by qualitatively comparing image(s) of a test specimen and
a user-defined standard, with or without the use of a body mimic, or quantitatively
determining the specific difference in optical density or pixel intensity between the
image of a test specimen and the image of a user-defined standard, with or without the
use of a body mimic.
NOTE. As a method standard, this Standard does not specify the acceptance criteria for X-ray
detectability, but for ease of use, Annex A recommends the acceptance criteria.

Basic Data

Standard ID	YY/T 0586-2016 (YY/T0586-2016)
Description (Translated English)	Medical polymer products - Test methods of radiopacity
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Classification of International Standard	11.040.20
Word Count Estimation	9,978
Date of Issue	2016-01-26
Date of Implementation	2017-01-01
Older Standard (superseded by this standard)	YY/T 0586-2005
Regulation (derived from)	China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies)	State Food and Drug Administration